Financial Data and Key Metrics Changes - For Q2 2019, the company reported a net loss of approximately $1.8 million or $0.08 per share, compared to a net loss of approximately $3.2 million or $0.14 per share for the same quarter in 2018, indicating an improvement in financial performance [30] - Research and development expenses decreased to approximately $940,000 from approximately $2.1 million year-over-year, primarily due to reduced clinical development costs and personnel expenses [31] - General and administrative expenses also decreased to approximately $875,000 from approximately $1 million year-over-year, largely due to lower professional fees [32] Business Line Data and Key Metrics Changes - The company is focused on advancing VAL-083 through two Phase 2 biomarker-driven clinical trials for MGMT-unmethylated glioblastoma, with significant progress reported in both trials [11][20] - The MD Anderson study has enrolled 46 out of a planned 48 patients, with completion expected soon, while the China study has enrolled 14 out of 30 patients [13][20] Market Data and Key Metrics Changes - The company is targeting the approximately 60% to 66% of newly diagnosed GBM patients with unmethylated MGMT status, who are underserved by current therapies [14] - The ongoing studies are expected to provide data that could inform treatment options for this specific patient population, which has a poor prognosis with existing therapies [14][43] Company Strategy and Development Direction - The company aims to extend its cash resources to support ongoing clinical trials and is optimistic about the potential for VAL-083 to improve overall survival in GBM patients [9][27] - There is a strategic focus on the MGMT-unmethylated population to expedite the approval process for VAL-083, as this group is believed to require fewer patients to demonstrate efficacy [51][56] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the ongoing Phase 2 studies and their potential to mitigate risks associated with NASDAQ compliance [27] - The company is committed to a fiscally responsible approach while exploring additional oncology indications for VAL-083, contingent on the success of current trials [23] Other Important Information - The company received an extension from NASDAQ until June 25, 2019, to regain compliance with the minimum bid price requirement [27] - A recent publication highlighted the unique mechanism of action of VAL-083, suggesting potential for combination therapies in treating other cancers [25] Q&A Session Summary Question: Can you talk about the MDACC study and what can be learned from it? - Management discussed the dosing strategy and the importance of focusing on the MGMT-unmethylated population, which has shown poor responses to current therapies [42][43] Question: How is methylated status determined and what impact could data from China have? - Management confirmed that the testing for methylated status is well-established and that positive data from China could significantly alter treatment expectations for unmethylated GBM patients [48][53] Question: Is the decision to focus on unmethylated GBM patients a business strategy? - Management clarified that the focus on this population is a strategic decision to expedite trials and reduce costs, not a limitation of VAL-083's efficacy [51][56]
Kintara Therapeutics(KTRA) - 2019 Q2 - Earnings Call Transcript